12 results · 20ms · Sources: EU EUDAMED, US FDA

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HORIZON 2000 TRANSCUTANEOUS GAS MONITORING

FDA 510(k)
FDA Class 2 ·Anesthesiology

P.F.C.

FDA UDI
DEPUY (IRELAND)·10603295215455·P.F.C. TIBIAL TRAY FIXED BEARING MODULAR PLUS 4...

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011860124000·Standard Band, Tooth 15-14/24-25, Size 24

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011860124180·Standard Band, Tooth 15-14/24-25, Size 24/Roth 18

N.A.

FDA UDI
DENTAURUM GmbH & Co.KG·J011860124220·Standard Band, Tooth 15-14/24-25, Size 24/Roth 22

ATRIUM FLIXENE GRAFT

FDA 510(k)
FDA Class 2 ·Cardiovascular

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

FDA 510(k)
FDA Class 2 ·Orthopedic

WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010

FDA Adverse Event
Death ·BOSTON SCIENTIFIC - GALWAY·Product code MUM·October 7, 2010

MESH - VENTRALEX

FDA Adverse Event
Injury ·DAVOL INC·Product code FTL·November 29, 2012

CAPSUREFIX MRI SURESCAN

FDA Adverse Event
Injury ·MPRI·Product code NVN·June 10, 2014

Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

FDA Enforcement
Class II ·Ongoing·Philips North America Llc·October 1, 2025

OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

FDA Enforcement
Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012